ADHD, Executive Dysfunction, Impulsive Aggression
Conditions
Keywords
DBT, aggression, ADHD, biomarkers, executive functions
Brief summary
This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.
Interventions
BEHAVIORALDialectical behavioral therapy skills for the intervention experimental group A
Our hypothesis is that impulsive aggression as evidenced by inflammatory biomarkers might improve by targeting executive dysfunctions with Dialectical Behavioural Therapy skills modules directed to the children and their parents in the form of response inhibition dysfunctions with Dialectical Behavioural Therapy mindfulness and distress tolerance skills modules, emotion regulation executive dysfunctions with Dialectical Behavioural Therapy emotion regulation skills module and socioenvironmental factors with interpersonal effectiveness and walking the middle path Dialectical behavioural therapy skills modules.
the control group (group B) will receive psychoeducation and medications targeting ADHD symptoms (Atomoxetine or stimulants according to FDA approved dose according to age and weight ) according to the international guidelines for management of ADHD according to symptom severity
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized control clinical trial
Eligibility
Sex/Gender
MALE
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Patients from 6 to 13-year-old. * Patients diagnosed with ADHD and presented with impulsive aggression. * Commitment to therapy from the child and the parent. * Written consent of all the children parents. * Male gender. * Drug naïve or stopped medications for at least one month.
Exclusion criteria
* Patients younger than 6 years of age as it's the starting age for DBT-C. * Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent. * Patients diagnosed with drug abuse. * Patients with severe sensory impairment or intellectual disability. * Drug induced aggression as levetiracetam, topiramate and benzodiazepines. * Patients diagnosed with Autism spectrum disorder or psychotic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impulsive aggression severity | Change from Baseline at 12 month | Using Modified overt aggression scale ,This scale rates the patient's aggressive behavior regarding four types of aggression (verbal, against objects, against self, against others) to give a total MOAS score about the patient's aggressive behavior. Each type of aggression had a rating of 0 when aggression was absent and four levels of severity. Weighted scores are then added together to yield the total score. |
| Biomarkers of aggression 1 | Change from Baseline 12 month | quantitative CRP |
| Biomarkers of aggression 2 | Change from Baseline 12 month | interleukin 6 |
| Biomarkers of aggression 3 | Change from Baseline 12 month | Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Executive dysfunctions severity | Change from Baseline 12 month | using Barkley Deficits In Executive Functioning Scale - Children and Adolescents ,The manuals indicate that results from the scale can be interpreted using normative comparisons (percentile scores based on sex and age group |
| ADHD symptom severity | Change from Baseline 12 month | using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity |
Countries
Egypt
Outcome results
None listed